Trial Information
A Multicenter Study of LY188011 in Anthracyclines and Taxanes Pre-treated Metastatic/Recurrent Breast Cancer
Inclusion Criteria:
- Histologically and/or cytologically confirmed breast cancer
- Received prior chemotherapy for metastatic breast cancer with anthracycline and
taxane regimen
- To have at least one measurable region
- PS: 0-1
- To have adequate organ function (bone marrow, liver and renal function)
Exclusion Criteria:
- To have Interstitial pneumonia or pulmonary fibrosis
- To have inflammatory carcinoma
- Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the
latest hormonal/immunotherapy or 7 days after surgery
- To have brain metastasis with symptom
- To have severe complication (cardiac infarction, infection, drug hyper sensitivity or
diabetes)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor Response
Outcome Description:
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Outcome Time Frame:
baseline to measured progressive disease
Safety Issue:
No
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
9065
NCT ID:
NCT00191269
Start Date:
June 2005
Completion Date:
March 2010
Related Keywords:
- Metastatic Breast Cancer
- after
- anthracycline
- taxane
- regimen
- Breast Neoplasms